A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Novartis rMenB+OMV NZ Vaccine in Healthy Subjects Aged 11 to 17 years in Korea.

ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 264 人开始时间: 2014年12月3日最近更新: 2014年12月8日

适应症

试验速览

暂无简介。

•In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
•Individuals eligible to be enrolled into this study are male and female subjects:
•1. 11-17 years of age inclusive who have given their written assent and whose parent or legal guardian has given written informed consent at the time of enrollment;
•2. Who are available for all the visits scheduled in the study (i.e. not planning to leave the area before the end of the study period);
•3. In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
•4. With a negative urine pregnancy test (for female subjects only).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 264
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•In order to participate in this study, all subjects must meet NONE of the exclusion criteria described below:
•1. History of any meningococcal vaccine administration;
•2. Current or previous, confirmed or suspected disease caused by N. meningitidis;
•3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
•4. Pregnancy or nursing (breastfeeding) mothers;
•5. Any serious chronic or progressive disease.
•6. Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives;
•7. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;

发起方

ovartis Vaccines and Diagnostics S.r.l.